Accelerating COVID-19 Therapeutic Development in Japanese Trial

This case study demonstrates how Signant SmartSignals eCOA supported Shionogi Pharmaceuticals' Phase II/III clinical trials for a COVID-19 therapeutic drug during the pandemic.

Facing challenges of remote monitoring requirements and rapid implementation needs, Shionogi leveraged Signant's solution to enable real-time tracking of patient-reported symptoms, blood oxygenation levels, and body temperatures across 90+ sites in four countries.

Signant's flexible implementation approach enabled patient enrollment to begin within just ten weeks of trial kick-off in Japan, and only six weeks in South Korea following trial expansion.

The system's real-time monitoring capabilities and 24/7 multilingual helpdesk support ensured high-quality data through improved patient compliance, facilitating reliable assessment of the drug's efficacy and safety.

This success story illustrates how Signant's "Four S" approach — Solution, Science, Scale, and Service — provided Shionogi with the technical capabilities, evidence generation expertise, multinational support, and global project management needed to successfully conduct complex clinical research during challenging pandemic conditions.